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. 2015 Jan 8;372(2):174-80.
doi: 10.1056/NEJMsr1414226. Epub 2014 Dec 24.

The proposed rule for U.S. clinical trial registration and results submission

Deborah A Zarin  1 , Tony Tse, Jerry Sheehan
Affiliations

The proposed rule for U.S. clinical trial registration and results submission

Deborah A Zarin et al. N Engl J Med. .
No abstract available

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Figures

Figure 1
Figure 1. Cumulative Number of Registered Studies from February 2000 to September 2014 and Key Events
Although the relevant Declaration of Helsinki (DoH) paragraphs apply to “every research study involving human subjects” (i.e., interventional and observational studies), the other listed key policies apply to interventional studies only. AE denotes adverse event, FDAAA Food and Drug Administration Amendments Act, FDAMA Food and Drug Administration Modernization Act, ICMJE International Committee of Medical Journal Editors, NPRM Notice of Proposed Rulemaking, and WHO World Health Organization.
Figure 2
Figure 2. Cumulative Number of Registered Clinical Trials with at Least One U.S. Site from October 2008 to September 2014
Completed clinical trials are shown according to completion date, and completed clinical trials with posted results are shown according to the results-submission date. The data reflect records posted on ClinicalTrials.gov as of November 26, 2014. The Study Completion Date data element was used when the Primary Completion Date data element was not listed.
See this image and copyright information in PMC

References

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